Positive results from MEMBRANE trial published in JAMA Neurology – Johnson & Johnson

Johnson & Johnson announced publication of the primary results from the MEMBRANE randomized controlled trial in JAMA Neurology. The study showed that adding middle meningeal artery embolization (MMAe) with TRUFILL n-BCA to standard of care (SOC), was associated with reduced cSDH recurrence and re-intervention versus standard of care alone.

MEMBRANE is a prospective, multicenter, open-label randomized controlled trial that randomized 376 patients across 30 sites in the United States and China, evaluating MMA embolization across both surgical and non-surgical chronic subdural hematoma treatment pathways. Participants treated with SOC plus MMAE with TRUFILL n‑BCA were significantly less likely to meet the prespecified composite primary end point of residual or re‑accumulation of cSDH >10mm or the need for surgical re‑intervention within 6 months than those treated with SOC alone. This corresponds to a 47% reduction in odds.

“These results reinforce the growing clinical evidence supporting middle meningeal artery embolization as an important treatment strategy for chronic subdural hematoma,” said Christian Cuzick, Worldwide President, Neurovascular, MedTech, Johnson & Johnson. “The MEMBRANE study adds meaningful randomized evidence demonstrating that embolization with TRUFILL n-BCA can help reduce recurrence and re-intervention while supporting positive patient outcomes.”

Additional findings from the MEMBRANE study included:
i) The embolization group had a numerically lower all‑cause mortality at six months (3.3% vs 8.4%).

ii) At 3 months, 85.3% vs 77.0% achieved good functional outcomes; MMAE met the trial’s non‑inferiority threshold

iii) High procedural success, with successful embolization achieved in 98.9% of cases

“Chronic subdural hematoma remains a challenging condition with meaningful risk of recurrence, particularly in elderly and medically complex patients,” said Chris Kellner, MD, Cerebrovascular Center, Mount Sinai Health System, and MEMBRANE Study Co-Principal Investigator. “The MEMBRANE data provide important evidence that middle meningeal artery embolization with TRUFILL n-BCA can reduce recurrence and the need for additional intervention while demonstrating an encouraging safety profile.”

Chronic subdural hematoma is a common neurological condition, particularly in aging populations, and is associated with substantial morbidity, mortality, and healthcare utilization. Publication of the MEMBRANE results in JAMA Neurology adds to the growing body of randomized clinical evidence supporting middle meningeal artery embolization as part of comprehensive chronic subdural hematoma management.